MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II EXTENSION STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number ETCF3636C49EJ

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Device Damaged by Another Device (2915)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2021

Event Type  Injury  

Event Description

An endurant iis bifurcated stent graft was implanted during an endovascular procedure for the treatment of a ruptured abdominal aortic aneurysm.Non mdt limbs were implanted on both sides.External iliac artery (eia) landing was performed on the right internal iliac artery (iia) plug.During the index procedure, after final angiography a leak was found so an endurant aortic extension was implanted.At the time of touch up, a unknown balloon interfered with a suprarenal stent and burst.So even though the balloon was raised from the right contralateral side, it got caught in the suprarenal stent and was difficult to be retrieved.The balloon was retrieved somehow, but the type ia endoleak was still remaining.Performing a chevar procedure was considered but the physician judged that additional treatment would be difficult due to the morphology of the suprarenal stent.Since it was not possible to place the patient under observation since it was a rupture case, the physician opted for an open y graft replacement and explanted the bifurcated stent graft and the cuff.  as per the physician the cause of the event was due to the patients vessel morphology and stated evar treatment was difficult.No additional clinical sequalae was provided and the patient is fine.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

B5;additional information received : it was confirmed that 3 reliant balloons were used in the procedure and ruptured.In the two of them, the shape of the centre was poor, and there was a part where the suprarenal stent floated.It seemed that the inflated balloon came into contact with suprarenal stents and ruptured.The other balloon passed through the inside of the suprarenal stent which was lifted from the contralateral side with the guidewire floating, and then was stuck and ruptured while the balloon was being retrieved.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12967359
• MDR Text Key: 281976105
• Report Number: 9612164-2021-04782
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: ETCF3636C49EJ
• Device Catalogue Number: ETCF3636C49EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2021
• Date Device Manufactured: 06/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 88 YR
• Patient Sex: Female